A Medical Device Daily

The Epilepsy Therapy Project (ETP; Middleburg, Virginia) and the Epilepsy Foundation (EF; Landover, Maryland) reported awarding a new therapy grant to potentially help those with treatment resistant epilepsy.

This grant was awarded to Alexander Rotenberg, MD, PhD, Assistant Professor of Neurology, Children's Hospital Boston, and will support a clinical study to evaluate the repetitive transcranial magnetic stimulation (rTMS) H-Coil as a promising non-invasive method of inhibiting the abnormal electrical activity believed to underlie seizures in focal temporal lobe epilepsy (TLE). Seizures originating in this part of the brain are often difficult to treat and resistant to existing therapies.

“Temporal lobe epilepsy accounts for nearly 20% of all epilepsy and an estimated 70 percent of drug resistant focal epilepsy cases. rTMS is a new therapeutic intervention of immediate importance to patients with poor seizure control,“ said Rotenberg. “This award will speed the development of this approach to deep brain stimulation to treat temporal lobe epilepsy.“

Rotenberg's program is based upon the premise that seizures may be managed by applying deep magnetic stimulation delivered around the head by the H-Coil technology to areas of the brain such as the temporal lobe, an area where many seizures start. The rTMS technology is approved for use in the treatment of major depression and other neuropsychiatric syndromes in Europe and Israel and marketed by Brainsway (Jerusalem).

Repetitive transcranial magnetic stimulation is a safe and painless method for focal brain stimulation, where small electrical currents inside the brain are induced by a powerful fluctuating magnetic field from outside the brain. Previous testing of low frequency rTMS did reduce brain excitability and suppressed seizures in some patients, but not in patients with TLE. However, the H-Coil's stronger effect penetrates into deeper brain regions.

Rotenberg and his research team hypothesize that rTMS with the H-Coil, designed to generate sufficient magnetic field strength, can safely and effectively stimulate deeper brain structures and may inhibit the electrical and neurotransmitter activity that underlies seizures in TLE. Their hypothesis is based in part on the encouraging antiepileptic effect of conventional rTMS in other types of epilepsy, and on their animal studies which showed that deeper brain stimulation by rTMS can suppress seizures in rats. The New Therapy Grant will support a clinical study of the H-Coil in children and adults with intractable TLE.

If this study shows the expected effect in seizure control, the H-Coil could rapidly move to commercialization for TLE treatment because a different version of the H-Coil that targets other deep brain areas is already marketed for treatment of major depression and other neuropsychiatric syndromes.